Clinical Trial

Clinical Trial Evaluating an Amnion Membrane Allograft for Use in the Management of Non- Healing Diabetic Foot Ulcers Versus Standard Of Care

Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated January 10, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.
Summary
The main purpose of this research study is to compare the proportion of wound closure in subjects that receive E-GRAFT™ with Standard of Care (SOC) versus FIBRACOL™ with SOC. Other research purposes include the following: * Rate of wound closure * Change in ulcer size over 12 weeks * Any adverse events or reactions (side effects) * Changes in neuropathy (nerve damage) * Change in pain levels * Occurrence of infection
Trial Details
NCT Number NCT06767501
Lead Sponsor Skye Biologics Holdings, LLC
Conditions Diabetic Foot Ulcers (DFUs)
Enrollment 100 participants
Start Date 2024-12-28
Primary Completion 2025-12 (estimated)
Study Completion 2025-12 (estimated)
Updated on ClinicalTrials.gov 2025-01-10